CurrentCignaPolicy N/A

Entyvio (vedolizumab) subcutaneous quantity management

This policy governs quantity limits and medically necessary exceptions for Entyvio SC (vedolizumab 108 mg prefilled pen) for treatment of Crohn's disease and ulcerative colitis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyEntyvio (vedolizumab) subcutaneous quantity management

Policy CodePolicy N/A

Change TypeNew policy — quantity limit overrides added

Effective DateN/A

Next Review DateAug 27, 2025

Key ActionFor exceptions, provide documentation of diagnosis, prior SC dosing history, and objective evidence of inflammation.

SourceLink

POLICY UPDATE CHANGES

New Policy was created to provide overrides to existing quantity limits.

108 mgstrength per prefilled pen

2 pens/28dretail max (standard)

6 pens/84dhome delivery max (standard)

4 pens/28dretail exception

12 pens/84dhome delivery exception

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria and Exceptions

Quantity Limit Exceptions (Increase to 4 pens/28 days or 12 pens/84 days)

Approve increased quantity (4 pens/28 days retail or 12 pens/84 days home delivery) when one of the following criteria groups is met.

Criteria Set 1

A: Entyvio is being used to treat Crohn's disease or ulcerative colitis
clinical indication required
B: Patient has received Entyvio 108 mg subcutaneous (SC) once every 2 weeks for 14 weeks or longer>= 14 weeks
document prior dosing duration
C: Prescriber reports continued evidence of inflammation based on one or more of: elevated C-reactive protein (CRP), elevated erythrocyte sedimentation rate (ESR), elevated fecal calprotectin, or signs of inflammation on endoscopic evaluationone or more
objective inflammatory markers or endoscopy

Criteria Set 2

A: Entyvio is being used to treat Crohn's disease or ulcerative colitis
clinical indication required
B: Patient has been receiving Entyvio 108 mg subcutaneous (SC) once weeklyQW dosing
ongoing weekly dosing documented

Any exception to the quantity limits for Entyvio (vedolizumab SC) that does not meet the specific criteria set forth in this policy will be considered not medically necessary. The Drug Quantity Limits and the enumerated exception pathways define the only covered overrides; requests that fall outside those pathways are not eligible for increased dispense and may be denied.

Requests to dispense quantities beyond the stated maximums (Retail: 2 pens per 28 days; Home Delivery: 6 pens per 84 days) that do not satisfy the documented exception criteria will be considered not medically necessary. Approval for larger quantities is only available when the policy's exception criteria are met and documented.

Product, Strength, and Quantity Limits

Covered product and strengthmixedCovered

vedolizumab SC 108 mg/0.68 mL

Entyvio prefilled pen strength and form

Drug quantity limits

Standard retail limit2 pens per 28 days (maximum)

Standard home delivery limit6 pens per 84 days (maximum)

Exception retail limitUp to 4 pens per 28 days when exception criteria are met

Exception home delivery limitUp to 12 pens per 84 days when exception criteria are met

Form and strengthEntyvio (vedolizumab) SC prefilled pen, 108 mg/0.68 mL

Provider Actions, Documentation, and Approval

Billing Rule

Quantity limit and approval duration

Quantity limits apply at point of service. If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the criteria in this policy. All approvals are provided for 1 year in duration unless otherwise noted.

Retail maximum quantity limit: 2 pens per 28 days
Home Delivery maximum quantity limit: 6 pens per 84 days

Prior Authorization

Dosing pathway and escalation

Entyvio therapy typically begins with IV induction (300 mg IV at Weeks 0, 2, and 6) with the option to switch to subcutaneous (SC) maintenance at Week 6 or at any scheduled IV infusion for patients with clinical response or remission. Recommended maintenance dosing for Entyvio SC is 108 mg SC every 2 weeks (Q2W). For patients with inadequate response on Q2W dosing, escalation to once weekly (QW) dosing is an option when clinically indicated (e.g., disease worsening, need for rescue medications, or need for surgical intervention) as supported by VISIBLE OLE data.

Background

Vedolizumab (Entyvio) subcutaneous is an integrin receptor antagonist indicated for moderately to severely active Crohn's disease and ulcerative colitis in adults. It is supplied as a 108 mg/0.68 mL prefilled pen; an intravenous 300 mg vial formulation is also available for induction dosing when clinically appropriate.

Standard supply limits are managed through this Drug Quantity Management program: the retail maximum is 2 pens per 28 days and the home delivery maximum is 6 pens per 84 days. The policy provides limited, evidence‑based exception pathways to allow increased quantities (up to 4 pens per 28 days retail or 12 pens per 84 days home delivery) when prespecified clinical criteria are met, such as prior SC dosing duration, ongoing objective evidence of inflammation, or documented weekly SC dosing.

Clinical dosing context: induction is typically with 300 mg IV at Weeks 0, 2, and 6, with maintenance using 108 mg SC every 2 weeks; dose escalation from every 2 weeks to once weekly is supported by available data for patients who do not achieve remission on Q2W dosing.

Dosing and Failure Definitions

Induction and maintenance

IV induction schedule300 mg IV at Weeks 0, 2, and 6

SC maintenance schedule108 mg SC once every 2 weeks (Q2W) for maintenance; may transition to SC at Week 6 or at any scheduled IV infusion for responders

Dose escalation optionFor inadequate responders on Q2W, escalation to 108 mg SC once weekly (QW) is supported by VISIBLE OLE data

Treatment failure (for escalation)

Definition of treatment failureDisease worsening, need for rescue medications, or need for surgical intervention (as defined in VISIBLE OLE)

Context for escalationVISIBLE OLE allowed escalation from Q2W to QW for patients meeting the treatment failure definition

Policy Summary

PayerCigna

PolicyEntyvio (vedolizumab) subcutaneous quantity management

Policy CodePolicy N/A

Change TypeNew policy — quantity limit overrides added

Effective DateN/A

Next Review DateAug 27, 2025

Key ActionFor exceptions, provide documentation of diagnosis, prior SC dosing history, and objective evidence of inflammation.

SourceLink

On This Page

IV induction: 300 mg IV at Weeks 0, 2, and 6
Maintenance: 108 mg SC Q2W
Dose escalation: Q2W -> QW for treatment failure per prescriber assessment

Denial Risk

Quantity limit noncompliance

Requests that exceed the Drug Quantity Limits above and do not meet the Exception Criteria (see criteria below) will be considered not medically necessary and may be denied. Exceptions to the quantity limits are only covered when the documented criteria are met; any other exception is considered not medically necessary.

Noncompliance with quantity limits without meeting Exception Criteria may result in denial at point of service

Documentation Required

Required clinical documentation for exception

For exception requests to exceed quantity limits, provide documentation demonstrating ALL applicable items: diagnosis, prior SC dosing history, duration of therapy, and objective evidence of ongoing inflammation or justification for weekly dosing. Specifically, include:

Confirmed diagnosis of Crohn's disease or ulcerative colitis
Documentation that the patient has received Entyvio 108 mg SC once every 2 weeks for at least 14 weeks when requesting escalation to 4 pens per 28 days (or 12 pens per 84 days) based on ongoing inflammation
If requesting approval based on weekly dosing, documentation that the patient has been receiving Entyvio 108 mg SC once weekly
Objective evidence of continued inflammation (one or more): elevated C-reactive protein, elevated erythrocyte sedimentation rate, elevated fecal calprotectin, or endoscopic findings
Prescriber statement describing clinical rationale for dose escalation (e.g., disease worsening, need for rescue therapy, or surgical intervention)

Evidence of benefit after escalationVISIBLE OLE reported clinical remission and response rates post-escalation (examples provided in study results)